Italian 
English DOCUMENTI SIBIOC - SIBioC Documents
Volume:
Biochimica Clinica 2019; 43(2) 228-243
Pubblicato on-line:
Maggio 25, 2019
DOI:
10.19186/BC_2019.047
Protocollo operativo per la verifica della comparabilità dei risultati di laboratorio ottenuti su più procedure analitiche
AUTORI
1SCDU Biochimica Clinica, AOU Maggiore della Carità, Novara
2Dipartimento di Medicina-DIMED, Università degli Studi di Padova
3Laboratorio Analisi, Ospedale dell'Angelo, ULSS 3 Serenissima, Mestre
4Laboratorio Analisi, ASST Spedali Civili di Brescia
5Servizio di Medicina di Laboratorio, Ospedale San Raffaele, Milano
6Laboratorio di Patologia Clinica, ASST Valcamonica, Esine (BS)
7Unità Operativa Complessa Medicina di Laboratorio, Azienda Ospedale-Università degli Studi di Padova
8Laboratorio Analisi, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milano
ABSTRACT
Protocol to verify the comparability of quantitative laboratory results obtained with different measurementprocedures.
With the growth and merging of clinical laboratories, very frequently analytical tests are performed onmultiple instruments within one or multiple locations. In these situations, there is the need of verifying thecomparability of patient results obtained with different analysers and/or different measurement procedures. Theimportance of this verification is further emphasised when considering that it is included into the ISO 15189specifications. This protocol provides step-by-step guidance on how to assess results comparability in differentscenarios. Up to four experimental designs are presented to meet laboratories’ needs, with details and examples onfrequency of testing, definition of acceptability criteria, samples selection, sample size calculation, statistical analysisand reporting.